CQV
Job in
Harrisburg, Dauphin County, Pennsylvania, 17101, USA
Listed on 2026-07-01
Listing for:
Kasmo Global
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Pharma Engineer, Validation Engineer, Process Engineer, Quality Engineering
Job Description & How to Apply Below
Cqv Engineers
Cqv engineers are responsible for supporting commissioning, qualification, and validation projects for pharmaceutical facilities, utilities, equipment, and systems. You will play a key role in executing cqv deliverables and ensuring operational readiness from the ground up to support our clients' success.
- Assist in commissioning and startup of new equipment, utilities, and cleanroom systems during facility buildout.
- Develop and execute iq/oq/pq protocols for newly installed systems and equipment.
- Prepare and maintain documentation, including validation protocols, plans, reports, and standard operating procedures.
- Support risk assessments and mitigation strategies related to cqv activities.
- Troubleshoot and assist in resolving issues related to equipment and process performance.
- Collaborate with cross-functional teams to align cqv activities with construction and project timelines.
- Coordinate with vendors and contractors to support hand-offs and system turnover.
- Ensure compliance with regulatory requirements (fda, ema, etc.) and industry standards (gmp, gamp, etc.).
- Provide technical support during validation execution and qualification activities.
- Additional responsibilities as required.
Requirements
- Bachelor's degree in engineering or a related field.
- 7-10 years of commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.
- Proven experience supporting or leading cqv activities during new facility buildouts, including equipment installation and startup.
- Strong background in cleanroom facilities, process equipment, and utility systems.
- Familiarity with project execution and project management tools.
- Deep understanding of regulatory requirements and industry standards (gmp, gamp, fda, ema).
- Knowledge of validation lifecycle and risk-based approaches.
- Excellent analytical and technical problem-solving skills.
- Strong technical writing skills and experience with validation documentation (protocols, reports, procedures, etc.).
- Effective communication and interpersonal skills.
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